Histopathology Following CCH Injection | Clinical Trial

Key information

Conditions

Characteristics of Subcutaneous Tissue

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Endo Clinical Trial Site #1, Montclair, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Be adequately informed and understand the nature and risks of the study and be able to provide consent.
Be undergoing planned elective abdominoplasty.
Be willing to have their tissue donated for evaluation.
Be judged to be in good health.
Have a negative pregnancy test.
Be willing and able to cooperate with the requirements of the study.

Exclusion criteria

Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
Has local (in the areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
Required use of anticoagulant or antiplatelet medication (except ≤ 150 mg aspirin daily) before or during participation in the trial.
Past history of any abdominal surgery, including but not limited to: liposuction, caesarean section, appendectomy, cholecystectomy, or umbilical hernia repair.
Has used or intends to use any local applications/therapies/injections/procedures that restricts study participation.
Is presently nursing or providing breast milk in any manner.
Intends to become pregnant during the study.
Intends to initiate an intensive sport or exercise program regimen during the study.
Intends to use any tanning spray or tanning booths during the study.
Has received any investigational drug or treatment within 30 days prior to first injection of study drug.
Has a known systemic allergy to collagenase or any other excipient of study drug.
Has received any collagenase treatment at any time prior to treatment in this study.
Any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.

Treatment and study plan

Collagenase Clostridium Histolyticum Single Injection Technique

Drug

CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.

Other names: EN3835, CCH

Collagenase Clostridium Histolyticum Multiple Injection Technique

Drug

CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.

Other names: EN3835, CCH

Primary outcomes

Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH

Time frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported.

Secondary outcomes

Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection

Time frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in a tissue specimen injected with 2 CCH dose injections (Treatment Area 1) relative to 1 CCH dose injection (Treatment Area 2) is reported.
Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment

Time frame: End of Study (Day 28)

Serum samples were analyzed for anti-AUX-I clostridial class I collagenase of ADAs and anti-AUX-II Clostridial class II collagenase of ADAs. The number of participants who developed anti-AUX-I and anti-AUX-II ADAs (positive ADA result) are reported.
Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment

Time frame: End of Study (Day 28)

Serum samples were analyzed for anti-AUX-I and Anti-AUX-II Nabs. The number of participants who developed anti-AUX-I and Anti-AUX-II NAbs (positive NAb results) are reported. Neutralizing antibodies were only tested from ADA positive participants.

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jan 22, 2020
Registry last updated: Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.